Senior Manager of Validation Engineering

INCOG BioPharma; Fishers (IN); On-site; USD 130,000 - 185,000; Full time

Job summary

INCOG BioPharma in Fishers, IN seeks a Senior Manager of Validation Engineering to lead CQV activities for sterile injectables manufacturing and packaging. You will partner with internal and external customers to meet client project needs, capital expansion initiatives, and maintain validated state, influencing outcomes across the organization.

The role requires 10+ years in Validation with 8+ years GMP experience, plus 5+ years of supervision, and is onsite at our Fishers campus.

Qualifications

• Bachelor's degree or higher in a STEM discipline, preference in an engineering or life science discipline.
• 10+ years of experience in Validation or related discipline.
• 8+ years GMP experience or other regulated industry.
• 5+ years of supervisory experience.
• Physically capable of working onsite.

Responsibilities

• Lead the Validation department with CQV activities for utilities, equipment and associated systems (clean utilities, steam sterilization, depyrogenation, cleaning, filling, inspection, packaging and labeling).
• Review and approve CQV lifecycle documentation.
• Develop and maintain validation lifecycle documents, templates, validation strategies and policies.
• Support site change management, including risk assessment and GMP activities.
• Assess risks in processing steps related to equipment and validation requirements/design deliverables.
• Interact with clients to provide validation support including product launches, new equipment qualifications, audits.
• Review and provide technical expertise to regulatory filings and support health authority inspections.
• Support validation oversight for capital expansion projects and develop CQV schedules.
• Collaborate with Engineering and Operations to monitor validation and process improvement efforts.

Skills

CQV leadership

Validation engineering

Regulatory filings

GMP experience

Risk assessment

Project management

Client interaction

Onsite leadership

Education

Bachelor's degree in STEM

Engineering or life sciences degree

Job description

The Senior Manager of Validation Engineering is responsible for understanding and implementing validation requirements for a sterile injectables manufacturing and packaging facility. The ideal candidate has practical experience in qualification and validation as well as leadership experience. The Senior Manager of Validation Engineering will partner with internal and external customers to meet the needs of client projects, capital expansion projects, and maintenance of the validated state. They will possess a demonstrated ability to influence positive outcomes and have direct reporting authority.Additionally, they must thoroughly understand and be able to adapt to the changing needs of a manufacturing environment.

Essential Job Functions:

• Lead the Validation department with Commissioning, Qualification and Validation (CQV) activities for utilities, equipment and associated systems. This includes, but is not limited to, clean utilities, steam sterilization and depyrogenation, manual and automated cleaning, filling, inspection, packaging and labeling, etc.
• Review and approve CQV lifecycle documentation.
• Support and oversee development and maintenance of validation lifecycle documents, document templates, validation strategies and policies.
• Support site change management program, including risk assessment and evaluation of required testing and GMP activities.
• Assess risks involved in processing steps related to equipment, developing and/or reviewing validation requirements and design deliverables.
• Interact with clients to provide validation support including, but not limited to, customer product launches, new equipment qualifications, audits, etc.
• Review and provide technical expertise to regulatory filings, and support health authority inspections.
• Support and provide validation oversight for capital expansion projects/build outs. This includes development and maintenance of CQV schedule for capital projects.
• Engage in a cross functional team and work closely with other supporting groups including Engineering and Operations to support and monitor validation and process improvement efforts.

Special Job Requirements:

• Bachelor's degree or higher in a STEM discipline, preference in an engineering or life science discipline
• 10+ years of experience in Validation or related discipline
• 8+ year GMP experience required or other regulated industry
• 5+ years of supervisory experience
• Physically capable of working onsite

Additional Preferences:

• Aseptic Fill and Finish Experience
• Experienced with cleaning validation, steam and dry heat sterilization and depyrogenation, inspection and packaging
• Strong working knowledge of regulatory requirements, risk-based guidance, and industry expectations
• Continuous improvement certification, i.e., Lean Six Sigma, or similar practices

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.